Anlotinib Hydrochloride Capsule: Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor that inhibits both tumor angiogenesis and tumor cell proliferation simultaneously.
Study summary
This is a real world study aiming to observe the efficacy and safety of Anlotinib capsules in patients with advanced medullary thyroid carcinoma, and to summarize the treatment experience in a broad population of patients.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Patients voluntarily joined the study, signed the informed consent, and had good compliance;
* Patients ≥18 years of age (at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-2; Expected survival of more than 3 months;
* Patients were pathologically confirmed as inoperable locally advanced or metastatic medullary thyroid carcinoma (MTC), possessing imaging or clinical evidence of disease progression within the first 14 months of enrollment;
* Having at least one measurable lesion (assessed by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1);
* Major organ functions meet the following criteria within 7 days prior to the treatment:
1. Blood routine examination shall meet the following standards (no transfusion within 14 days) :
1. Hemoglobin (Hb) ≥85g/L;
2. Absolute Neutrophil Count (ANC) ≥1.5×109/L;
3. Platelet (PLT) ≥80×109/L;
2. Biochemical examination shall meet the following standards:
1. Total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN);
2. Alanine transferase (ALT) and Aspartate transferase (AST) ≤2.5×ULN; If accompanied by liver metastasis, ALT and AST ≤5×ULN;
3. Serum creatinine (Cr) ≤1.5×ULN or Creatinine clearance rate (CCr) ≥60ml/min;
* Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period until six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period until six months after the end of the study.
Exclusion Criteria:
* Complicated diseases and history:
1. Patients currently have or had other malignancies within 3 years. Patients with the following two conditions can be included in the group: Continuous 5-year disease-free survival (DFS) was achieved for other malignancies treated with a single operation. Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (the tumor infiltrates the basal membrane)\];
2. Major surgical treatment, open biopsy, or significant traumatic injury were received within 28 days before the beginning of the treatment;
3. Subjects with any severe and/or uncontrolled disease, including:
1. Having ≥ grade 2 myocardial ischemia or myocardial infarction or arrhythmia (including QTc ≥450ms (male), QTc ≥470ms (female) and ≥ grade 2 congestive heart failure (classified by New York heart association, NYHA));
2. Active or uncontrolled severe infection (≥ Common Terminology Criteria for Adverse Events (CTC AE) 2 grade of infection);
3. Renal failure requiring hemodialysis or peritoneal dialysis;
* Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
* Patients who have previously used anlotinib hydrochloride capsules or similar Vascular Endothelial Growth Factor- Tyrosine Kinase Inhibitor (VEGFR-TKI) small molecule drugs, such as vandetanib, cabozantinib, lenvatinib, sunitinib, sorafenib, etc.;
Primary outcome measure(s)
Overall Response Rate (ORR) — Baseline up to 3 years. The proportion of subjects who achieves a best overall response of complete response (CR) or partial response (PR).
Progression-free Survival (PFS) — Baseline up to 3 years. From the first dose of investigational drug to the date of disease progression or death, whichever occurs first.
Trial sites (19)
Facility
City
Region
Status
Anhui Provincial Cancer Hospital
Hefei
Anhui
Not Yet Recruiting
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing
Beijing Municipality
Recruiting
Gansu Cancer Hospital
Lanzhou
Gansu
Recruiting
Guangxi Zhuang Autonomous Region Cancer Hospital (Affiliated Cancer Hospital of Guangxi Medical University)
Nanning
Guangxi
Not Yet Recruiting
The First Affiliated Hospital of Hebei North University
Shijiazhuang
Hebei
Recruiting
Tianjin Cancer Hospital
Tianjin
Hebei
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Hubei Cancer Hospital
Wuhan
Hubei
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Not Yet Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University
Nanjing
Jiangsu
Recruiting
Jiangsu North People's Hospital
Yangzhou
Jiangsu
Recruiting
Liaoning Cancer Hospital and Institute
Shenyang
Liaoning
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an
Shanxi
Recruiting
Shanxi Provincial Tumor Hospital
Xi’an
Shanxi
Not Yet Recruiting
Tianjin People's Hospital
Tianjin
Tianjin Municipality
Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming
Yunnan
Recruiting
Zhejiang Provincial People's Hospital
Hangzhou
Zhejiang
Recruiting
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.